Budesonide rectal

Indications

Budesonide rectal is used for: Ulcerative Colitis

Adult Dose

Ulcerative Colitis Indicated for the induction of remission in patients with active mild-to-moderate distal ulcerative colitis extending up to 40 cm from the anal verge 1 metered dose (2 mg) PR BID for 2 weeks followed by 1 metered dose PR once daily in evening for 4 weeks

Child Dose

Renal Dose

Administration

For rectal administration only; not for oral use Before administration, use the bathroom to empty your bowels Each applicator is coated with a lubricant; if additional lubrication is needed, petrolatum or petroleum jelly can also be used Warm the canister in the hands while shaking it vigorously for 10-15 seconds before use Can be used in a standing, lying, or sitting position (eg, while using the toilet) When applied in the evening, use immediately prior to bedtime; try not to empty your bowels again until the next morning

Contra Indications

Hypersensitivity

Precautions

Long-term use of corticosteroids may cause hypercorticism and adrenal suppression Taper systemic corticosteroids slowly when transitioning from corticosteroids with higher systemic effects to those with lower effects (eg, budesonide rectal); symptoms attributed to withdrawal of steroid therapy, including those of acute adrenal suppression or benign intracranial hypertension, may develop Corticosteroids (prolonged use or high doses) are known to be immunosuppressive; monitor patients with active or quiescent tuberculosis infection, ocular herpes simplex, or untreated fungal, bacterial, systemic viral, or parasitic infections Monitor patients with hypertension, diabetes mellitus, osteoporosis, peptic ulcer, glaucoma, or cataracts; any family history of diabetes or glaucoma; or with any other conditions in which glucocorticosteroids may have unwanted effects Moderate-to-severe hepatic impairment; monitor for increased signs and/or symptoms of hypercorticism Avoid use of strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, ritonavir, indinavir, saquinavir, erythromycin, grapefruit juice) during 6-week treatment period; may increase budesonide systemic exposure Rectal foam is flammable; store away from flame or heat sources

Pregnancy-Lactation

Pregnancy Category: C Lactation: Rectal foam is likely to result in budesonide in human milk as budesonide delivered by inhalation from a dry-powder inhaler is present in human milk at low concentrations

Interactions

Adverse Effects

Side effects of Budesonide rectal : >10% Decreased blood cortisol (17%) 1-10% Adrenal insufficiency (4%) Nausea (2%) <1% Insomnia (0.4%) Sleep disorder (0.4%) Acne (0.4%) Depression (0.4%) Hyperglycemia (0.4%)

Mechanism of Action

Elicits glucocorticosteroid activity, including anti-inflammatory effects